NCT04271137Unknown不适用
Evaluation of Orbital Reconstruction Using Patient Specific 3-D Printed Onlay Versus Pre-Bent Titanium Mesh
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Enophthalmos
研究概览
简要总结
this study evaluates the post-surgical correction of enophthalmos and orbital volume using 3D printed only versus pre-bent titanium mesh in blow-out fracture cases
详细描述
Many materials had been used in reconstruction of blow out fractures, the aim of this study is to evaluate the enophthalmos correction and orbital volume restoration using 3D printed onlay versus pre-bent titanium mesh
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (≤17 years old).
- •Blow-out Orbital Fracture.
- •Unilateral Orbital Trauma.
- •Enophthalmos (≤ 2 mm).
- •Patients with contralateral healthy, non-surgically operated orbit.
排除标准
- •Young Patients (> 17 years old).
- •Patients with Systemic diseases.
- •Bilateral Orbital Trauma.
- •Enophthalmos (>2 mm).
- •Patients whom cannot tolerate follow up intervals.
结局指标
主要结局
Enophthalmos
时间窗: 1 year post-operative
CT based - corneal projection from lateral orbital rim measured in millimeters
次要结局
- Implant position accuracy(One week post-operative)
- Orbital volume(one week post-operative)
研究者
Mohamed Salah
Principal investigator
Cairo University
研究点 (2)
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